21cfr1271

§ 1271.47

21 CFR Ch. I (4–1–06 Edition)

has been determined to be eligible, except as provided under §§ 1271.60(d),
1271.65(b), and 1271.90 of this subpart.
(d) Applicability of requirements. If you
are an establishment that performs
any function described in this subpart,
you must comply with the requirements contained in this subpart that
are applicable to that function.
[69 FR 29830, May 25, 2004, as amended at 69
FR 68681, Nov. 24, 2004]

§ 1271.47 What procedures must I establish and maintain?
(a) General. You must establish and
maintain procedures for all steps that
you perform in testing, screening, determining donor eligibility, and complying with all other requirements of
this subpart. Establish and maintain
means define, document (in writing or
electronically), and implement; then
follow, review, and as needed, revise on
an ongoing basis. You must design
these procedures to ensure compliance
with the requirements of this subpart.
(b) Review and approval. Before implementation, a responsible person must
review and approve all procedures.
(c) Availability. Procedures must be
readily available to the personnel in
the area where the operations to which
they relate are performed, or in a nearby area if such availability is impractical.
(d) Departures from procedures. You
must record and justify any departure
from a procedure relevant to preventing risks of communicable disease
transmission at the time of its occurrence. You must not make available for
distribution any HCT/P from a donor
whose eligibility is determined under
such a departure unless a responsible
person has determined that the departure does not increase the risks of communicable
disease
transmission
through the use of the HCT/P.
(e) Standard procedures. You may
adopt current standard procedures,
such as those in a technical manual
prepared by another organization, provided that you have verified that the
procedures are consistent with and at
least as stringent as the requirements
of this part and appropriate for your
operations.

§ 1271.50 How do I determine whether
a donor is eligible?
(a) Determination based on screening
and testing. If you are the establishment responsible for making the donoreligibility determination, you must determine whether a donor is eligible
based upon the results of donor screening in accordance with § 1271.75 and
donor testing in accordance with
§§ 1271.80 and 1271.85. A responsible person, as defined in § 1271.3(t), must determine and document the eligibility of a
cell or tissue donor.
(b) Eligible donor. A donor is eligible
under these provisions only if:
(1) Donor screening in accordance
with § 1271.75 indicates that the donor:
(i) Is free from risk factors for, and
clinical evidence of, infection due to
relevant communicable disease agents
and diseases; and
(ii) Is free from communicable disease
risks
associated
with
xenotransplantation; and
(2) The results of donor testing for
relevant communicable disease agents
in accordance with §§ 1271.80 and 1271.85
are negative or nonreactive, except as
provided in § 1271.80(d)(1).
§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete;
and what records must I retain?
(a) Accompanying records. Once a
donor-eligibility determination has
been made, the following must accompany the HCT/P at all times:
(1) A distinct identification code affixed to the HCT/P container, e.g., alphanumeric, that relates the HCT/P to
the donor and to all records pertaining
to the HCT/P and, except in the case of
autologous donations, directed reproductive donations, or donations made
by first-degree or second-degree blood
relatives, does not include an individual’s name, social security number, or
medical record number;
(2) A statement whether, based on
the results of screening and testing,
the donor has been determined to be eligible or ineligible; and
(3) A summary of the records used to
make the donor-eligibility determination.
(b) Summary of records. The summary
of records required by paragraph (a)(3)

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